Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

NCT03743324 | Unknown DMC

• 1 other identifier: E2018210
• Study Type: observational
• Target: 1,344
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.

Conditions

Breast Cancer

Keywords

breast reconstruction; Chinese; radiation; timing

Outcome Measures

Primary Outcomes (3)

• occurrence of short term complications

  impaired arterial or venous flap perfusion by increased (\>3 seconds) or reduced (\<2 seconds) capillary refill time; infection of the reconstructed breast with evidences from microbiological cultures; partial or entire flap necrosis with evident demarcation by clinical observation

  the short term complications will be inspected up to 3 months post-op;

• occurrence and change of long term complications

  fat necrosis proven by breast ultrasound/ breast MRI/ pathology; flap contracture that causes change in shape and/or volume in the reconstructed breast mound observed by naked-eye inspection or breast imaging; capsular contracture that causes hardness/pains or changes of the reconstructed breast mound observed by surgeon's inspection or breast imaging.

  the long term complications will be assessed at 6 months post-op; repeated assessments will be made at 12 and 24 months to record changes

• occurrence of secondary surgery

  unplanned surgery due to short-term and/or long-term complications post-op, the types of secondary surgery include but not limited to exploratory surgery, flap salvages, removal or fat necrosis, debridement, prosthetic explantation.

  up to 24 months post-op

Secondary Outcomes (2)

• occurrence of revision surgery

  6 to 24 months post-op

• baseline and change of subjective evaluation

  the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes

Study Arms (3)

BR group

Breast reconstruction without radiation therapy

Procedure: Immediate Breast reconstruction; Procedure: Delayed Breast Reconstruction

Immediate BR +post-op radiation

Immediate breast reconstruction followed by surgical site radiation therapy

Procedure: Immediate Breast reconstruction; Radiation: Radiation

Radiation +delayed BR

previous post-mastectomy radiation followed by delayed breast reconstruction

Procedure: Delayed Breast Reconstruction; Radiation: Radiation

Interventions

Immediate Breast reconstruction PROCEDURE

Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer

BR group; Immediate BR +post-op radiation

Delayed Breast Reconstruction PROCEDURE

Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer

BR group; Radiation +delayed BR

Radiation RADIATION

Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy

Immediate BR +post-op radiation; Radiation +delayed BR

Eligibility Criteria

• Gender Eligibility Details: Female breast patients who have natural breasts
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population include female Chinese breast cancer patients who wish to undergo autologous or prosthetic-based breast reconstruction.

You may qualify if:

• Diagnosed with breast cancer
• Karnofsky Performance Status (KPS) larger than 70
• Underwent autologous or prosthetic based breast reconstruction
• No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

You may not qualify if:

• Metastatic breast cancer
• Local recurrence after mastectomy
• Prior radiation history to chest wall due to other tumors
• Radiation performed more than 6 months after mastectomy
• Interruption of radiation more than 2 weeks
• Gravida or during lactation
• Concurrently undergoing psychotic disorders

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Related Publications (14)

• Schaverien MV, Macmillan RD, McCulley SJ. Is immediate autologous breast reconstruction with postoperative radiotherapy good practice?: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1637-51. doi: 10.1016/j.bjps.2013.06.059. Epub 2013 Jul 22.

  PMID: 23886555 BACKGROUND

• Berbers J, van Baardwijk A, Houben R, Heuts E, Smidt M, Keymeulen K, Bessems M, Tuinder S, Boersma LJ. 'Reconstruction: before or after postmastectomy radiotherapy?' A systematic review of the literature. Eur J Cancer. 2014 Nov;50(16):2752-62. doi: 10.1016/j.ejca.2014.07.023. Epub 2014 Aug 26.

  PMID: 25168640 BACKGROUND

• Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20.

  PMID: 21336948 BACKGROUND

• Kelley BP, Ahmed R, Kidwell KM, Kozlow JH, Chung KC, Momoh AO. A systematic review of morbidity associated with autologous breast reconstruction before and after exposure to radiotherapy: are current practices ideal? Ann Surg Oncol. 2014 May;21(5):1732-8. doi: 10.1245/s10434-014-3494-z. Epub 2014 Jan 29.

  PMID: 24473643 BACKGROUND

• Losken A, Nicholas CS, Pinell XA, Carlson GW. Outcomes evaluation following bilateral breast reconstruction using latissimus dorsi myocutaneous flaps. Ann Plast Surg. 2010 Jul;65(1):17-22. doi: 10.1097/SAP.0b013e3181bda349.

  PMID: 20548235 BACKGROUND

• Selber JC, Kurichi JE, Vega SJ, Sonnad SS, Serletti JM. Risk factors and complications in free TRAM flap breast reconstruction. Ann Plast Surg. 2006 May;56(5):492-7. doi: 10.1097/01.sap.0000210180.72721.4a.

  PMID: 16641623 BACKGROUND

• Chang EI, Liu TS, Festekjian JH, Da Lio AL, Crisera CA. Effects of radiation therapy for breast cancer based on type of free flap reconstruction. Plast Reconstr Surg. 2013 Jan;131(1):1e-8e. doi: 10.1097/PRS.0b013e3182729d33.

  PMID: 23271550 BACKGROUND

• Kronowitz SJ. Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012 Oct;130(4):513e-523e. doi: 10.1097/PRS.0b013e318262f059.

  PMID: 23018711 BACKGROUND

• Pestana IA, Campbell DC, Bharti G, Thompson JT. Factors affecting complications in radiated breast reconstruction. Ann Plast Surg. 2013 May;70(5):542-5. doi: 10.1097/SAP.0b013e31827eacff.

  PMID: 23542851 BACKGROUND

• Chatterjee JS, Lee A, Anderson W, Baker L, Stevenson JH, Dewar JA, Thompson AM. Effect of postoperative radiotherapy on autologous deep inferior epigastric perforator flap volume after immediate breast reconstruction. Br J Surg. 2009 Oct;96(10):1135-40. doi: 10.1002/bjs.6693.

  PMID: 19787763 BACKGROUND

• Rogers NE, Allen RJ. Radiation effects on breast reconstruction with the deep inferior epigastric perforator flap. Plast Reconstr Surg. 2002 May;109(6):1919-24; discussion 1925-6. doi: 10.1097/00006534-200205000-00022.

  PMID: 11994594 BACKGROUND

• Yueh JH, Slavin SA, Adesiyun T, Nyame TT, Gautam S, Morris DJ, Tobias AM, Lee BT. Patient satisfaction in postmastectomy breast reconstruction: a comparative evaluation of DIEP, TRAM, latissimus flap, and implant techniques. Plast Reconstr Surg. 2010 Jun;125(6):1585-1595. doi: 10.1097/PRS.0b013e3181cb6351.

  PMID: 20517080 BACKGROUND

• Lam TC, Hsieh F, Boyages J. The effects of postmastectomy adjuvant radiotherapy on immediate two-stage prosthetic breast reconstruction: a systematic review. Plast Reconstr Surg. 2013 Sep;132(3):511-518. doi: 10.1097/PRS.0b013e31829acc41.

  PMID: 23676964 BACKGROUND

• He S, Yin J, Robb GL, Sun J, Zhang X, Li H, Liu J, Han C. Considering the Optimal Timing of Breast Reconstruction With Abdominal Flaps With Adjuvant Irradiation in 370 Consecutive Pedicled Transverse Rectus Abdominis Myocutaneous Flap and Free Deep Inferior Epigastric Perforator Flap Performed in a Chinese Oncology Center: Is There a Significant Difference Between Immediate and Delayed? Ann Plast Surg. 2017 Jun;78(6):633-640. doi: 10.1097/SAP.0000000000000927.

  PMID: 27798424 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Jian Yin

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanshan He

CONTACT

+86-22-23340123; ssh85@yahoo.com

Jian Yin

CONTACT

+86-22-23340123; yinjian@tjmuch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 16, 2018
• Study Start: January 1, 2019
• Primary Completion: November 1, 2022
• Study Completion: April 1, 2023
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share